Director, GMP Quality Assurance

Role Summary

Director, GMP Quality Assurance Biologics. The successful candidate will serve as the primary Quality Assurance representative for Disc Medicine's Biologics pipeline, providing strategic and hands-on QA oversight for late-stage clinical trials, technology and method transfer, clinical manufacturing, and batch disposition. Reports to the Executive Director, GMP Quality Assurance, Biologics.

Responsibilities

• Provide quality partnership and oversight of Disc Medicine's Biologics manufacturing, testing and disposition of products (Biologics) and combination products (Biologic + Device) processes. Experience with prefilled syringes (PFS) and safety device assembly is required.
• Support ongoing technology transfer of drug product and device manufacturing processes and analytical methods to external CDMOs, ensuring late-stage GMP requirements to support pivotal clinical trials.
• Ensure compliance in the Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations (FDA, EU, ICH, ISO 13485, QMSR, MDR). Experience with Japanese regulatory requirements beneficial.
• Collaborate with cross-functional teams to draft, review and verify documents for Health Authority CMC submissions, including verification of documents, records, protocols, reports, and data.
• Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of combination products, including deviations, investigations, change controls and CAPA.
• Partner with internal stakeholders to ensure program alignment and timely delivery of quality milestones.
• Identify and escalate quality risks while driving effective, compliant resolutions and fostering a quality culture in a fast-paced, matrixed environment.

Qualifications

• Bachelor's Degree in a scientific discipline or related field.
• 12-15 years of progressive Quality Assurance experience, with experience in Technology Transfer, Global QMS design/implementation, and managing combination products (prefilled syringes required).
• Hands-on expertise with Combination Products (Device and Biologic) including developing QMS processes that guide manufacturing, QC testing, and supply chain.
• Proven track record in building a quality culture with experience in GMP operations, quality agreements, vendor management, investigations, change management, and inspection readiness.
• Experience with CMC, development programs, quality management reviews, and vendor joint steering committees.
• Desirable experience across clinical development of biologics (Pre-Clinical to Licensure) and direct discussions with Health Authorities.
• Self-driven, highly organized, with proven ability to build cross-functional relationships and communicate complex issues clearly.
• Ability to travel nationally and internationally (10-20%).

Skills

• Quality Assurance leadership
• GMP compliance (FDA, EU, ICH, ISO 13485, MDR)
• Technology Transfer and Vendor/CMC management
• Risk-based quality systems; deviations, investigations, CAPA
• Cross-functional collaboration and communication
• Regulatory submissions support

Education

• Bachelor's Degree in a scientific discipline (required).

Additional Requirements

• Ability to travel 10-20% nationally and internationally.